This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.

Eligibility

Ages Eligible for Study:

16 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.

Are at least 16 years old.

Have signed consent of parent or guardian if under 18 years of age.

Are willing to use effective barrier methods of birth control.

Are available for follow-up for at least 52 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have had anti-HIV treatment within 30 days before screening.

Have a recently diagnosed HIV-related infection.

Have any medical condition requiring treatment at enrollment.

Have recently become HIV infected.

Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.

Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A4.

Abuse alcohol or drugs.

Have severe diarrhea within 30 days before study entry.

Are pregnant or breast-feeding.

Have a history of hemophilia.

Have a history of bilateral peripheral neuropathy.

Cannot take medicines by mouth.

Have any other conditions that the doctor thinks would interfere with the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013897